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“Current Approach of Quality by Design” An Overview

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“Current Approach of Quality by Design” An Overview


R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude



R. Kavi Bharathi | R. Sanil Kumar | Shantaram Nangude "“Current Approach of Quality by Design” An Overview" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-1, February 2023, pp.1374-1384, URL: https://www.ijtsrd.com/papers/ijtsrd53873.pdf

In this Analysis, we'll look at how QbD is being practised right now. QbD represents a cutting-edge methodology for enhancing the safety and efficacy of pharmaceuticals. Quality by Design (QbD) is a relatively new idea in the pharmaceutical industry, but it has quickly become an integral aspect of the current approach to quality. Quality by Design relies on the ICH Guidelines as its basis. Guidelines Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems from the International Council for Harmonization (ICH) served as inspiration for this document. QbD is the most effective method now available for improving the quality of all pharmaceutical goods, but it poses a significant problem for the pharmaceutical business, whose procedures are traditionally static. Eventually, despite inevitable process and material variation, It is crucial to establish the desired product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and to pinpoint the attributes of quality that are most important to the product's success throughout the QbD process (CQA). We may then use this information to tailor the product's composition and production method to those characteristics. This results in the identification and management of sources of variability and an understanding of the effect of raw materials [critical material attributes (CMA)] and critical process parameters (CPP) on critical quality attributes (CQAs). To which the process and technique of development must have access. Quality-by-Design (QbD) encompasses the processes of drug development and manufacturing. that guarantees the product meets the standards set out in advance.

Quality By Design, Pharmaceutical Quality, ICH Guidelines, Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes, Critical Process Parameter, Process development, Product Specification


IJTSRD53873
Volume-7 | Issue-1, February 2023
1374-1384
IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470
Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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